Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,694 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 11, 2017	Total Hip Pack, part number PSS2956	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Major Kit, part number PHC1307(A	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Transvaginal Pack, part number CMP1767	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Knee Pack, part number AMS4211	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Orbitofacial Pack, part number AMS5850(A	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Ortho Pack, part number PSS3466(A	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Major Pack (1345), part number AMS6565	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Surgical Pack, part number PSS3540(A	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Minor/General/Ortho Pack, part number PSS3258(B	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	General Surgery Pack, part number PSS1380(A	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Upper Torso Tray, part number PSS1554(B	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Jan 11, 2017	Nasal Pack, part number PSS2186	The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ...	Class II	Windstone Medical Packaging, Inc.
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 23, 2016	BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ...	Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n...	Class II	Becton Dickinson & Company
Dec 12, 2016	AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG...	Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Pr...	Class II	Medtronic Navigation, Inc.
Dec 9, 2016	Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M...	During internal testing conducted as part of next generation product development, it was discover...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Nov 16, 2016	Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion...	Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio...	Class II	Medtronic Inc
Nov 10, 2016	ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross...	Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire...	Class II	Medtronic Inc
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 4, 2016	Covidien Clearify Visualization System Item Code: 21-345 Intended to be us...	Product sterility is compromised due to breach of the sterile barrier	Class II	Medtronic
Oct 4, 2016	Best Practices kits containing certain production lots of Clearify Visualizat...	Product sterility is compromised due to breach of the sterile barrier	Class II	Medtronic
Oct 3, 2016	Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h...	Medtronic has identified an increased number of complaints from customers involving reports of Re...	Class II	Medtronic Neuromodulation
Oct 3, 2016	Medtronic SynchroMed II Implantable Drug Infusion System. This system includ...	Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th...	Class I	Medtronic Neuromodulation
Sep 22, 2016	Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:...	O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 1, 2016	Visualase Body Accessory Kit PN 020-3000. The individual components within th...	Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty...	Class II	Medtronic Navigation, Inc.
Sep 1, 2016	Visualase Visualization Stylets PN 020-2301. The individual components within...	Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty...	Class II	Medtronic Navigation, Inc.
Aug 12, 2016	Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016	Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product...	78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 5, 2016	CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the...	Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ...	Class II	Medtronic Inc.
Aug 3, 2016	Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-...	Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).	Class II	Medtronic Cardiovascular Surgery-the Heart Valv...
Jul 18, 2016	MACH Cranial Treon. The software application is sent in CD format with an IFU...	Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt...	Class II	Medtronic Navigation, Inc.
Jul 18, 2016	MACH AxiEM Cranial Treon. The software application is sent in CD format with ...	Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt...	Class II	Medtronic Navigation, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.